Natco Pharma Receives USFDA Warning Letter for Telangana Plant

9 Apr 2024 , 03:34 PM

Natco Pharma recently disclosed that it has received a warning letter from the US Food and Drug Administration (USFDA) concerning its Telangana-based manufacturing plant. This letter follows an inspection of Natco Pharma’s Kothur-based formulation facility by the USFDA from October 9 to 18, 2023, during which eight observations were noted under Form 483.

In a regulatory filing, Natco Pharma informed shareholders about the issuance of the warning letter dated April 8, 2024. Despite this development, the company stated its belief that the warning letter would not significantly affect supplies or revenues from the facility. However, it acknowledged the possibility of delays or withholding of pending product approvals from the site due to the letter’s issuance.

Natco Pharma assured stakeholders that it would respond promptly to the warning letter within the specified timelines. The company expressed its commitment to working closely with the USFDA to address the concerns raised and ensure sustained compliance with regulatory standards. It emphasized the importance of a holistic and timely approach to resolving the issues outlined in the warning letter.

A warning letter from the US health regulator signifies significant violations of regulations by the manufacturer. Nevertheless, Natco Pharma remains dedicated to maintaining compliance and upholding quality standards in its operations.

Meanwhile, on the stock market, Natco Pharma’s shares were trading 0.97% higher at ₹990.30 per share on the Bombay Stock Exchange (BSE). The company is a major player in the pharmaceutical industry, specializing in branded oncology medicines, hepatitis C drugs, and affordable complex medicines. With its commitment to compliance and quality, Natco Pharma continues to be a prominent presence in the healthcare sector, both domestically and internationally.

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